Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Estraimod Immediate Release · 1 trial · 1 indication
AUClast was calculated using linear/log trapezoidal method.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 2 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 3 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 4 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Name | Type | Description |
|---|---|---|
| Estraimod Immediate Release (IR) | DRUG | an immediate release tablet |
| Etrasimod Mini Tab in water | DRUG | very small tablet mixed in water |
| Etrasimod Mini Tab in chocolate pudding | DRUG | very small tablet mixed in chocolate pudding |
| Etrasimod Mini Tab in yogurt | DRUG | Very small tablet mixed in yogurt |
| Etrasimod Mini Tab in applesauce | DRUG | Very small tablet mixed in applesauce |
Inclusion Criteria: * Healthy participants * BMI 16 to 32 kg/m2 * body weight more than 50kg Exclusion Criteria: * Ongoing or past history of significant medical conditions * Eye disorders such as macular edema or uveitis * Ongoing or recent infections * Use of prescription or non prescription me...
Estraimod Immediate Release is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a completed trial evaluating the study medication when mixed with food. The drug is not approved and remains under investigation.
Estraimod Immediate Release is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational small molecule in healthy participants.
Estraimod Immediate Release is in Phase 1 clinical development. One Phase 1 trial has been completed, which enrolled 16 healthy participants in Belgium. The drug is investigational and has not been approved for any use.
Estraimod Immediate Release has one completed clinical trial, NCT05956002, titled "A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants." This Phase 1 study enrolled 16 healthy adults aged 18 years and older in Belgium.
Yes, Estraimod Immediate Release is the same as Etrasimod. The clinical trial NCT05956002 refers to the study medication as Etrasimod, and the drug is being evaluated in healthy participants. Both names refer to the same investigational small molecule.